Oral Iron Supplementation on Alternate Vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy

Last updated: December 10, 2024
Sponsor: Southern Illinois University
Overall Status: Active - Recruiting

Phase

4

Condition

Anemia

Pregnancy

Treatment

daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Clinical Study ID

NCT06492512
21-924
  • Ages 18-45
  • Female

Study Summary

This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) withlaboratory confirmed IDA (as defined by hemoglobin under 10.5 g/dL, as well asferritin under 15 mcg/L)

Exclusion

Exclusion Criteria:

  • Patients <18 years old, patients who have severe IDA that requires blood transfusionor IV iron infusion, patients who have other known hemoglobinopathy (such asthalassemia or sickle cell anemia) or anemia of different mechanism (such as vitaminB12 or folate deficiency), patients with ulcerative colitis, Crohn's disease,gastric ulcers, patients who have previously undergone gastric bypass surgery,patients who experience admission for antepartum bleed, have been diagnosed withabnormal placentation (i.e., placenta previa, placenta accreta, placenta increta orpercreta)

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
Phase: 4
Study Start date:
December 01, 2024
Estimated Completion Date:
June 30, 2028

Study Description

During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.

Connect with a study center

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Active - Recruiting

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